Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a Phase 2 clinical trial in adult hypogonadal males with baseline morning serum testosterone concentrations <300 ng/dL. The purpose of this study is to evaluate the pharmacokinetics of FE 999303, delivered using an applicator in comparison to hand application
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Testosterone 2.50 mL (hand) | Experimental | Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by hand, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm every day for seven days. |
|
| Testosterone 1.25 mL (applicator) | Experimental | Subjects in this arm self-applied one stroke (1.25 mL) of testosterone gel by applicator to the shoulder/upper arm every day for seven days. |
|
| Testosterone 2.50 mL (applicator) | Experimental | Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm every day for seven days. |
|
| Testosterone 3.75 mL (applicator) | Experimental | Subjects in this arm self-applied three strokes (3.75 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm and a third stroke to the first shoulder/upper arm, every day for seven days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testosterone Gel (FE 999303) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Responder Rate: Percentage of Subjects Whose Average Steady State Concentration (Cavg) of Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL Following Treatment With Each of Three Volumes of FE 999303 Applied With an Applicator. | Descriptive statistics was used to present the outcome results. | Days 15-21, Days 22-28 & Days 29-35 |
| Measure | Description | Time Frame |
|---|---|---|
| Responder Rate: Percentage of Subjects Whose Cavg Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL Following Treatment With One Volume of FE 999303 Applied by Hand. | Days 1-7 | |
| Pharmacokinetics of Total Testosterone and DHT (Dihydrotestosterone) Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hrs. Post Dose (AUCτ) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AccuMed Research Associates | Garden City | New York | United States |
Apart from having history of hypogonadism, the study subjects were required to present with one or more symptoms of testosterone deficiency (i.e. fatigue, decreased muscle mass, reduced libido, reduced sexual functioning of a non-mechanical nature). The study subjects needed to be in good health despite exhibiting hypogonadism.
The study was conducted at one study site in the US. Out of 78 subjects screened, 20 subjects were enrolled in the study.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Testosterone Topical | Initially subjects self-applied 2.50 mL (two strokes) of testosterone gel by hand every day for seven days followed by a 7-day washout period. After washout period, subjects sequentially self-applied ascending doses of testosterone gel with the applicator; 1.25 mL (one stroke), 2.50 mL (two strokes), and 3.75 mL (three strokes), respectively every day for seven days with no washout period in between. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The data are presented for Intent-to-treat (ITT) population, which comprised of all subjects who received at least one dose of the Investigational Medicinal Product (IMP).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Testosterone Topical | Initially study subjects self-applied 2.50 mL (two strokes) of testosterone gel by hand every day for seven days followed by a 7-day washout period. After washout period, study subjects sequentially self-applied ascending doses of testosterone gel with the applicator; 1.25 mL (one stroke), 2.50 mL (two strokes), and 3.75 mL (three strokes), respectively every day for seven days with no washout period in between. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Responder Rate: Percentage of Subjects Whose Average Steady State Concentration (Cavg) of Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL Following Treatment With Each of Three Volumes of FE 999303 Applied With an Applicator. | Descriptive statistics was used to present the outcome results. | Full Analysis Set (FAS) population was used for this analysis, which comprised of all subjects who had any available Pharmacokinetic (PK) data. | Posted | Number | percentage of subjects | Days 15-21, Days 22-28 & Days 29-35 |
|
Overall Treatment Period (36 Days)
Adverse events with onset after start of the first IMP administration were considered treatment-emergent and are presented.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Testosterone 2.50 mL (Hand) | Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by hand, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm everyday for seven days. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | DK0-Disclosure@ferring.com |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator |
| Pharmacokinetics of Total Testosterone and DHT Measuring Time of Maximum Observed Concentration (Tmax) | Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator |
| Pharmacokinetics of Total Testosterone and DHT Measuring Maximum Concentration Observed (Cmax) | Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator |
| Pharmacokinetics of Total Testosterone and DHT Measuring Cavg | Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator |
| Pharmacokinetics of Total Testosterone and DHT Measuring Minimum Concentration Observed (Cmin) | Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator |
| Pharmacokinetics of Total Testosterone and DHT Measuring Time of Minimum Observed Concentration (Tmin) | Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator |
| Pharmacokinetics of Total Testosterone and DHT Measuring AUCτ | Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand |
| Pharmacokinetics of Total Testosterone and DHT Measuring Tmax | Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand |
| Pharmacokinetics of Total Testosterone and DHT Measuring Cmax | Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand |
| Pharmacokinetics of Total Testosterone and DHT Measuring Cavg | Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand |
| Pharmacokinetics of Total Testosterone and DHT Measuring Cmin | Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand |
| Pharmacokinetics of Total Testosterone and DHT Measuring Tmin | Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand |
| Year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | subjects |
|
| Height | Mean | Standard Deviation | inch |
|
| Weight | Mean | Standard Deviation | lbs |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm everyday for seven days. |
| OG002 | Testosterone 3.75 mL (Applicator) | Subjects in this arm self-applied three strokes (3.75 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm and a third stroke to the first shoulder/upper arm, everyday for seven days. |
|
|
| Secondary | Responder Rate: Percentage of Subjects Whose Cavg Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL Following Treatment With One Volume of FE 999303 Applied by Hand. | FAS population was used for this analysis, which comprised of all subjects who had any available PK data. | Posted | Number | percentage of subjects | Days 1-7 |
|
|
|
| Secondary | Pharmacokinetics of Total Testosterone and DHT (Dihydrotestosterone) Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hrs. Post Dose (AUCτ) | FAS population was used for this analysis, which comprised of all subjects who had any available PK data. | Posted | Mean | Standard Deviation | ng*hr/dL | Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator |
|
|
|
| Secondary | Pharmacokinetics of Total Testosterone and DHT Measuring Time of Maximum Observed Concentration (Tmax) | FAS population was used for this analysis, which comprised of all subjects who had any available PK data. | Posted | Median | Full Range | hr | Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator |
|
|
|
| Secondary | Pharmacokinetics of Total Testosterone and DHT Measuring Maximum Concentration Observed (Cmax) | FAS population was used for this analysis, which comprised of all subjects who had any available PK data. | Posted | Mean | Standard Deviation | ng/dL | Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator |
|
|
|
| Secondary | Pharmacokinetics of Total Testosterone and DHT Measuring Cavg | FAS population was used for this analysis, which comprised of all subjects who had any available PK data. | Posted | Mean | Standard Deviation | ng/dL | Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator |
|
|
|
| Secondary | Pharmacokinetics of Total Testosterone and DHT Measuring Minimum Concentration Observed (Cmin) | FAS population was used for this analysis, which comprised of all subjects who had any available PK data. | Posted | Mean | Standard Deviation | ng/dL | Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator |
|
|
|
| Secondary | Pharmacokinetics of Total Testosterone and DHT Measuring Time of Minimum Observed Concentration (Tmin) | FAS population was used for this analysis, which comprised of all subjects who had any available PK data. | Posted | Median | Full Range | hr | Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator |
|
|
|
| Secondary | Pharmacokinetics of Total Testosterone and DHT Measuring AUCτ | FAS population was used for this analysis, which comprised of all subjects who had any available PK data. | Posted | Mean | Standard Deviation | ng*hr/dL | Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand |
|
|
|
| Secondary | Pharmacokinetics of Total Testosterone and DHT Measuring Tmax | FAS population was used for this analysis, which comprised of all subjects who had any available PK data. | Posted | Median | Full Range | hr | Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand |
|
|
|
| Secondary | Pharmacokinetics of Total Testosterone and DHT Measuring Cmax | FAS population was used for this analysis, which comprised of all subjects who had any available PK data. | Posted | Mean | Standard Deviation | ng/dL | Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand |
|
|
|
| Secondary | Pharmacokinetics of Total Testosterone and DHT Measuring Cavg | FAS population was used for this analysis, which comprised of all subjects who had any available PK data. | Posted | Mean | Standard Deviation | ng/dL | Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand |
|
|
|
| Secondary | Pharmacokinetics of Total Testosterone and DHT Measuring Cmin | FAS population was used for this analysis, which comprised of all subjects who had any available PK data. | Posted | Mean | Standard Deviation | ng/dL | Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand |
|
|
|
| Secondary | Pharmacokinetics of Total Testosterone and DHT Measuring Tmin | FAS population was used for this analysis, which comprised of all subjects who had any available PK data. | Posted | Median | Full Range | hr | Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Testosterone 1.25 mL (Applicator) | Subjects in this arm self-applied one stroke (1.25 mL) of testosterone gel by applicator to the shoulder/upper arm everyday for seven days. | 0 | 20 | 0 | 20 |
| EG002 | Testosterone 2.50 mL (Applicator) | Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm everyday for seven days. | 0 | 20 | 0 | 20 |
| EG003 | Testosterone 3.75 mL (Applicator) | Subjects in this arm self-applied three strokes (3.75 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm and a third stroke to the first shoulder/upper arm, everyday for seven days. | 0 | 20 | 1 | 20 |
There is a restriction on joint publications prepared in collaboration between investigator and sponsor as Ferring reserves the right to be involved in this decision. In the event of any disagreement in the content of any publication both investigator's and Ferring´s opinion will be fairly and sufficiently represented in the publication.
|
|
|
|
|
|